Diabetes Attitudes Wishes and Needs

Diabetes Mellitus, Type 2 Clinical Trial

— DAWN2  

Official title:

Diabetes Attitudes Wishes and Needs (DAWN) 2 Study: A Multinational, Multi-stakeholder Survey Study of Psychosocial Issues in Diabetes and Patient-centred Diabetes Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01507116
• Other study ID #: INS-3966
• Secondary ID: U1111-1123-7509
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: January 18, 2017
• Start date: March 2012
• Est. completion date: September 2012

Study information

• Verified date: January 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study is conducted in Africa, Asia, Europe, Japan, North America and South America.

The multinational surveys will explore the experiences and unmet needs of people with diabetes, as well as those of family members of people with diabetes, and of healthcare professionals treating people with diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8985
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults aged at least 18 years with diabetes (type 1 or type 2: not only during pregnancy)

• Adults aged at least 18 years involved in the daily care of an adult (18 years or older) with diabetes (type 1 or type 2)

• General practitioners who personally treat at least 5 adults (18 years or older) with diabetes per month and initiate oral medication

• Diabetes specialists (endocrinologists/diabetologists) who personally treat at least 50 adults (18 years or older) with diabetes per month and prescribe oral medication, insulin or other injectable diabetes medications

• Diabetes educators (diabetes nurses/dieticians/other non-physician healthcare professionals) providing care for at least 5 adults (18 years or older) with diabetes per month

• Participants must have access to the internet, either at home or at a location convenient to them, or be able to attend a face-to-face or telephone interview, to participate in the survey

• Provision of informed consent before the start of any study-related activities

Exclusion Criteria:

• Individuals aged below 18 years and/or diagnosed with diabetes less than 12 months ago

• Inability to understand and comply with written and verbal instructions

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Healthcare Professionals
• Relatives to/Carers of Patients

Intervention

Other:
• No treatment given
Three separate survey questionnaires, one for each of the three diabetes groups. Each questionnaire is composed of multiple items including pre-coded (multiple choice) questions, dichotomous (yes/no) questions and rating scales.

Locations

Country	Name	City	State
Algeria	Novo Nordisk Investigational Site	Algiers
Canada	Novo Nordisk Investigational Site	Mississauga
China	Novo Nordisk Investigational Site	Beijing	Beijing
Denmark	Novo Nordisk Investigational Site	Copenhagen S
France	Novo Nordisk Investigational Site	Paris La défense cedex
Germany	Novo Nordisk Investigational Site	Mainz
India	Novo Nordisk Investigational Site	Bangalore
Italy	Novo Nordisk Investigational Site	Rome
Japan	Novo Nordisk Investigational Site	Tokyo
Mexico	Novo Nordisk Investigational Site	Mexico City
Netherlands	Novo Nordisk Investigational Site	Alphen a/d Rijn
Poland	Novo Nordisk Investigational Site	Warszawa
Russian Federation	Novo Nordisk Investigational Site	Moscow
Spain	Novo Nordisk Investigational Site	Madrid
Turkey	Novo Nordisk Investigational Site	Istanbul
United Kingdom	Novo Nordisk Investigational Site	Crawley
United States	Novo Nordisk Investigational Site	Princeton	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Countries where clinical trial is conducted

United States,  Algeria,  Canada,  China,  Denmark,  France,  Germany,  India,  Italy,  Japan,  Mexico,  Netherlands,  Poland,  Russian Federation,  Spain,  Turkey,  United Kingdom, 

References & Publications (6)

Funnell M. Beyond the data: moving towards a new DAWN in diabetes. Diabet Med. 2013 Jul;30(7):765-6. doi: 10.1111/dme.12244. — View Citation

Holt RI, Nicolucci A, Kovacs Burns K, Escalante M, Forbes A, Hermanns N, Kalra S, Massi-Benedetti M, Mayorov A, Menéndez-Torre E, Munro N, Skovlund SE, Tarkun I, Wens J, Peyrot M; DAWN2 Study Group.. Diabetes Attitudes, Wishes and Needs second study (DAWN — View Citation

Kovacs Burns K, Nicolucci A, Holt RI, Willaing I, Hermanns N, Kalra S, Wens J, Pouwer F, Skovlund SE, Peyrot M; DAWN2 Study Group.. Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national benchmarking indicators for family members livin — View Citation

Nicolucci A, Kovacs Burns K, Holt RI, Comaschi M, Hermanns N, Ishii H, Kokoszka A, Pouwer F, Skovlund SE, Stuckey H, Tarkun I, Vallis M, Wens J, Peyrot M; DAWN2 Study Group.. Diabetes Attitudes, Wishes and Needs second study (DAWN2™): cross-national bench — View Citation

Peyrot M, Burns KK, Davies M, Forbes A, Hermanns N, Holt R, Kalra S, Nicolucci A, Pouwer F, Wens J, Willaing I, Skovlund SE. Diabetes Attitudes Wishes and Needs 2 (DAWN2): a multinational, multi-stakeholder study of psychosocial issues in diabetes and per — View Citation

Peyrot M, Egede LE, Campos C, Cannon AJ, Funnell MM, Hsu WC, Ruggiero L, Siminerio LM, Stuckey HL. Ethnic differences in psychological outcomes among people with diabetes: USA results from the second Diabetes Attitudes, Wishes, and Needs (DAWN2) study. Cu — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-reported health and Quality of Life (QoL) (measured by the study questionnaire)		Day 1
Secondary	Psychological well-being of people with diabetes and family members measured by the study questionnaire		Day 1
Secondary	Diabetes distress of people with diabetes and family members measured by the study questionnaire		Day 1
Secondary	Self-reported self-management of people with diabetes measured by the study questionnaire		Day 1
Secondary	Family support behaviours reported by people with diabetes and family members measured by the study questionnaire		Day 1
Secondary	Patient-centred diabetes care reported by people with diabetes and health care professionals measured by the study questionnaire		Day 1

External Links

•   Clinical Trials at Novo Nordisk